Services platform
Production of eCTD / Nees / Paper dossiers
One dossier, several formats
The target is to issue a dossier which is fully compliant with the domestic Authority's required format.
According to the procedure, it can be necessary to produce several different formats for the same dossier.
The acceptability of a dematerialized regulatory submission depends on the local (per country) validation practices.
In order to guarantee a full technical compliance, ProductLife Group adapts its validation processes to the situation of each country involved in the procedure.
Even though the main target is an eCTD submission (Centralised procedure EMA, France, Switzerland, Czech Republic ...), other formats such as NeeS, can be relevant in some countries.
ProductLife Group has adapted its internal organization to rapidly and efficiently fit to all domestic requirements. We are also able to provide consulting services for short and mid-term strategy, according to your specific situation.
Production phase:
- Reception of documents
- eCTD compilation
1. Potential corrective actions to make your documents eCTD ready
2. Analysis of your source documents (via DVD-ROM, CD-ROM, FTP, eMAIL,...) and submission meta-data sheet
1. Creation of the eCTD structure and definition of dossier's specifications
2. Assignment of documents to the appropriate sections
3. Meta-data entry including those related to lifecycle management
4. Hyperlink checking: reset/ delete "broken" links set in the source documents but not functional within the context of publishing
5. Creation of hyperlinks linked to the submission: transformation of explicit cross reference into navigable and implicit hyperlinks
6. Compilation / Publishing of the electronic submission
7. Final checking of the entire submission
- Delivery of the dossier (via DVD-ROM, FTP,...) to the customer
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